Dr. Beukelman has received consulting fees, speaking fees, and/or honoraria from Novartis and Genentech (less than $10,000 each) and research funding from Pfizer.
Tumor necrosis factor α inhibitor therapy and cancer risk in chronic immune-mediated diseases†
Version of Record online: 27 DEC 2012
Copyright © 2013 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 65, Issue 1, pages 48–58, January 2013
How to Cite
Haynes, K., Beukelman, T., Curtis, J. R., Newcomb, C., Herrinton, L. J., Graham, D. J., Solomon, D. H., Griffin, M. R., Chen, L., Liu, L., Saag, K. G., Lewis, J. D. and on behalf of the SABER Collaboration (2013), Tumor necrosis factor α inhibitor therapy and cancer risk in chronic immune-mediated diseases. Arthritis & Rheumatism, 65: 48–58. doi: 10.1002/art.37740
Statements in this article should not be construed as endorsement by the Agency for Healthcare Research and Quality (AHRQ), FDA, or US Department of Health and Human Services (DHHS).
- Issue online: 27 DEC 2012
- Version of Record online: 27 DEC 2012
- Accepted manuscript online: 10 OCT 2012 08:31AM EST
- Manuscript Accepted: 2 OCT 2012
- Manuscript Received: 2 APR 2012
- FDA/DHHS. Grant Number: 1U18-HS-017919-0
- AHRQ Centers for Education and Research on Therapeutics Program
- NIH. Grant Numbers: 5KL2-RR-025776, AR- 053351, AHRQ grant R01-HS-018517, K24-DK07822806
- University of Alabama at Birmingham Center for Clinical and Translational Science
To compare the incidence of cancer following tumor necrosis factor α (TNFα) inhibitor therapy to that with commonly used alternative therapies across multiple immune-mediated diseases.
The Safety Assessment of Biological Therapeutics study used data from 4 sources: national Medicaid and Medicare databases, Tennessee Medicaid, pharmacy benefits plans for Medicare beneficiaries in New Jersey and Pennsylvania, and Kaiser Permanente Northern California. Propensity score–adjusted hazard ratios (HRs) and 95% confidence intervals (95% CIs) were computed to estimate the relative rates of cancer, comparing those treated with TNFα inhibitors to those treated with alternative disease-modifying therapies. The cancer-finding algorithm had a positive predictive value ranging from 31% for any leukemia to 89% for female breast cancer.
We included 29,555 patients with rheumatoid arthritis (RA) (13,102 person-years), 6,357 patients with inflammatory bowel disease (1,508 person-years), 1,298 patients with psoriasis (371 person-years), and 2,498 patients with psoriatic arthritis (618 person-years). The incidence of any solid cancer was not elevated in RA (HR 0.80 [95% CI 0.59–1.08]), inflammatory bowel disease (HR 1.42 [95% CI 0.47–4.26]), psoriasis (HR 0.58 [95% CI 0.10–3.31]), or psoriatic arthritis (HR 0.74 [95% CI 0.20–2.76]) during TNFα inhibitor therapy compared to disease-specific alternative therapy. Among RA patients, the incidence of any of the 10 most common cancers in the US and of nonmelanoma skin cancer was not increased with TNFα inhibitor therapy compared to treatment with comparator drugs.
Short-term cancer risk was not elevated among patients treated with TNFα inhibitor therapy relative to commonly used therapies for immune- mediated chronic inflammatory diseases in this study.